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[IP] =?UTF-8?Q?MiniMed=20Gets=20CE=20Mark=20for=20=E2=80=98Next=20Ge n?= =?UTF-8?Q?eration=E2=80=99=20Pump?=
got this off of www.best.com/diabetes
MiniMed Gets CE Mark for bNext Generationb Pump
On February 18, MiniMed Inc. announced that it had received approval to
Mark its next-generation, model MIP 2007 implantable insulin pump, enabling
its commercial distribution in Europe later this spring. MiniMed anticipates
the model arriving on the U.S. market sometime in 2001.
This pump, which is manufactured for MiniMed by an affiliated company,
Medical Research Group, Inc. (MRG), contains several technological
improvements, such as improved memory and a longer battery life, and is
lighter in weight than its predecessor, the model 2001 pump.
bThe MIP 2007 has a longevity of about 10 years for an average person with
type 1 diabetes as well as a number of other valuable advances,b says Alfred
E. Mann, chairman and CEO of MiniMed. bWith this extended life, the model
2007 becomes very cost effective.b
Implantable Artificial Pancreas
Mann points out that this new system has been designed so that it can be
joined with a long-term implantable glucose sensor being developed by MRG.
MiniMed has the option of acquiring exclusive marketing rights to MRGbs
bThis combination would create an implantable artificial pancreas, and early
technical feasibility experiments indicate that animal trials of such a
closed-loop system could be started later this year,b says Mann. bWe look
forward to the day we provide systems that will effectively eliminate most of
the risks and complexities of dealing with this awful disease.b
Not Yet Available in the States
Sales of the model 2007 implantable pump will be initiated in Europe, and are
expected to be limited until the specially formulated insulin, manufactured
by Aventis, is approved for commercial use. MiniMed spokespersons anticipate
this approval may occur before the end of this year or at the beginning of
Neither the implantable pump nor the special insulin has yet been cleared for
the market in the United States. The U.S. Food and Drug Administration (FDA)
expects to review the model 2007 pump and Aventis insulin concurrently.
MiniMed is working closely with Aventis to file these applications by
mid-2000, according to Robert Murtfeldt, director of product and business
development for MiniMed.
bWhile FDA approvals may occur sometime in 2001, historically, FDA reviews
implantable medical devices are extensive and may take longer than this
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